Orthopedic Pin KitRange of Implants

• Diameters: 1.5mm and 2.0mm

• Length: 40mm

Easy-to-Use Instruments• Adjustable inserters

• Disposable instrument set • Pin pusher, pin sleeve, pin K-wire/depth-stop

• Simple to use

Indications• Correction of hallux valgus

• Repair of metacarpal and phalangeal fusion and fractures

Weil-Carver™ Hammertoe

Orthopedic Pins

Large Screw System

Small Screw System

Plates, Sheets, Mesh Panel System

Propeller Head™ Small Cannulated Screw

Technical Information

General Guidelines for Pre-Measured Implant InsertionCreate Bone HoleA bone clamp or secondary K-wire (pack-aged separately) can be used to further stabilize the bone segments (Figure 1).

Drill with the provided K-wire/depth-stop assembly through the bone fragment and into the underlying bone (Figure 2). Intraoperative radiographic visualization can be used to guide K-wire placement.

Measure Hole for ReUnite® PinWith K-wire still in bone, slide depth-stop snug to bone (Figure 3).

Remove K-wire from bone and drill, being careful to not move the depth-stop. Read bone hole measurement from the proximal side of the depth-stop (Figure 4).

Figure 1

Figure 2

Figure 3

Figure 4

Trim ReUnite® Pin to Measured Tunnel LengthTrim pin to measured length by inserting the pusher into the ReUnite® Pin sleeve pushing the pin out of one end (Figure 5).

Stop inserting the pusher at pre-measured depth via markings on pusher (Figure 6). Trim off exposed pin using heat loop (Figure 7).

The remaining pin in sleeve corresponds to the bone hole depth.

Insert Pin Into HoleIrrigate the bone hole with sterile saline. Position the uncut end of the pin sleeve in line with the drilled bone hole. Introduce the non-cut end of the pin into the bone hole with the pin pusher by pushing or gently tapping the proximal knob of the pusher with a mallet to advance the pin into the bone hole (Figure 8).

Figure 5

Figure 6

Figure 7

Figure 8

Insert Pin into HoleIrrigate the bone hole with sterile saline. Position the pin sleeve in line with the drilled bone hole. Introduce the pin into the bone hole with the pin pusher by pushing or gently tapping the proximal knob of the pusher with a mallet to advance the pin into the bone hole (Figure 3).

Stop advancing pin when pin bottoms out in drilled tunnel. Trim exposed pin flush with bone (Figure 4)

General Guidelines for Non-Measured Implant InsertionCreate Bone HoleA bone clamp or secondary K-wire (pack-aged separately) can be used to further stabilize the bone segments (Figure 1).

Drill with the provided K-wire/depth-stop assembly through the bone fragment and into the underlying bone (Figure 2). Intraoperative radiographic visualization can be used to guide K-wire placement.

Figure 1

Figure 2

Figure 3

Figure 4

Ordering InformationResorbable Orthopedic Pin Kits

Part No. Size

948230 1.5 x 40mm 948231 2.0 x 40mm

Heat Loop905414

K-wire (optional)950092 0.62" (1.5mm) Sterile

Steinmann Pin (optional)950093 5/64" (2.0mm) Sterile

Refer to package insert for precautions, indications and warnings.

This brochure is presented to demonstrate the surgical technique utilized by Ron C. Clark, M.D., Valparaiso, Indiana. Arthrotek, as the manufacturer of this device, does not practice medicine and does not recommend this or any other system for use on a specific patient. The surgeon who performs any procedure is responsible for determining and utilizing the appropriate techniques for such procedure for use on a specific patient. Arthrotek is not responsible for selection of the appropriate product or surgical technique to be utilized for an individual patient.

ReUnite® is a trademark of Biomet Manufacturing Corp.

Completed Repair for Both Pre-Measured and Non-Measured Implant Insertion

Weil-Carver Hammertoe

Orthopedic Pins

Large Screw System

Small Screw System

Plates, Sheets, Mesh Panel System

Propeller Head™ Small Cannulated Screw

Technical Information

P.O. Box 587, Warsaw, IN 46581-0587 • 800.348.9500 • ©2005 Arthrotek, Inc. All Rights Reservedweb site: www.arthrotek.com • eMail: arthrotek@arthrotek.comForm No. Y-BMT-924/063005/K

Arthrotek, Inc. 01-50-1064A56 East Bell Drive Date 03/04P.O. Box 587 Warsaw, IN 46581-0587 USA

BIOMET RESORBABLE FIXATION DEVICESATTENTION OPERATING SURGEON

DESCRIPTIONBiomet resorbable fixation devices include screws, sheets, mesh, plates, rivets, and pins. Biomet resorbable fixation devices are made of a resorbable copolymer, polyester derivative of L-lactic and glycolic acids. Poly L-lactic / polyglycolic acid copolymer degrades and resorbs in- vivo by hydrolysis into L-lactic and glycolic acids which are then metabolized by the body.

INDICATIONS 1. The Lactosorb® Hand System is indicated for surgical fixation of

closed non-comminuted diaphyseal fractures in the presence of appropriate immobilization.

2. The LactoSorb® 5.0mm Washer is used in conjuction with the Biomet 5.0 mm Bone Screw for ankle fractures, metatarsal fusion, and metatarsal osteotomies (Hallux Valgus) in the presence of appropriate protection or immobilization (e.g. casting, bracing, external fixator etc.).

3. The 2.0 mm, 2.5mm and 3.5mm Resorbable Bone Screws, and Resorbable Bone Pins, are indicated for use in the presence of appropriate immobilization in the following procedures: correction of Hallux Valgus (bunion) and repair of metacarpal and phalangeal fusion and fractures.

4. The resorbable mesh, sheets, 2.5mm and 3.5mm screws, and 2.5mm rivets are indicated for maintaining the position of bony fragments or morselized bone graft in iliac crest autograft procedures. The Lactosorb® devices are not intended for use in spine or joint space. This product is not intended for pelvic fracture fixation.

5. The Resorbable Hammer Toe Pin is a resorbable device used for proximal interphalangeal joint (PIP) joint arthrodesis.

CONTRAINDICATIONS 1. Active Infection 2. Patients with mental or neurologic conditions who are unwilling or

incapable of following postoperative care instructions. 3. Patient conditions including, blood supply limitations, obesity,

insufficient quantity or quality of bone stock or latent infection. 4. Do not use in load bearing procedures (excluding 5.0 screws and

Hammer Toe Pins, see above indications).

WARNINGSInternal fixation devices aid the surgeon in the alignment and stabilization of skeletal fractures and provide a means of fracture management in reconstructive surgical applications. While these devices are generally successful in attaining these goals, they cannot be expected to replace normal healthy bone or withstand the stress placed upon the device by full or partial weight bearing or load bearing, particularly in the presence of nonunion, delayed union, or incomplete healing. Internal fixation devices are internal splints that align the fracture until normal healing occurs. The size and shape of bones and soft tissue place limitation on the size and strength of implants. If there is delayed union or nonunion of bone in the presence of weight bearing, or load bearing, the implant could eventually break. Therefore, it is important that immobilization (use of external support, walking aids, braces, etc.) of the fracture site be maintained until firm bone union (confirmed by clinical and radiographic examination) is established. Surgical implants are subject to repeated stresses in use, which can result in fatigue fracture. Factors such as the patient’s weight, activity level, and adherence to weight bearing or load bearing instructions have an effect on the service life of the implant. The surgeon must be thoroughly knowledgeable not only in the medical and surgical aspects of the implant, but also must be aware of the mechanical and metallurgical aspects of the surgical implants.

1. Correct selection of the implant is extremely important. The potential for success in fracture fixation is increased by the selection of the proper type of implant. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size and strength of implants. Internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal healthy bone. These devices are not designed to withstand the unsupported stress of full weight bearing, or load bearing.

2. Improper selection, placement, positioning, and fixation of the device can lead to failure of the device or the procedure. The surgeon is to be familiar with the devices, the method of application and the surgical procedure prior to performing surgery. The surgeon must select a type or types of internal fixation devices appropriate for treatment.

3. These devices are resorbable and do not provide permanent fixation. Do not use in procedures where a permanent implant is needed.

4. The plates can be heated and shaped as desired up to and including three times using the LactoSorb® Heat Pack or a hot sterile saline/water bath. LactoSorb® exposure to the bath should be a maximum of 15 seconds per bath with the temperature not exceeding 85° C. Do not heat Lactosorb� Resorbable Bone Screws by any means prior to implantation.

5. Correct handling of implants is extremely important. Do not modify implants. Do not notch or bend implants. Notches or scratches put in the implant during the course of surgery may contribute to breakage. Intraoperative fracture of devices can occur if excessive force (torque) is applied while seating.

6. The devices can break or be damaged due to excessive activity or trauma. This could lead to failure requiring additional surgery and device removal.

7. Discard and do not use previously opened or damaged devices. Use only devices that are packaged in unopened or undamaged containers.

8. Do not use if there is loss of sterility of the device. 9. When resorbable fixation devices are used to aid in the alignment

and stabilization of bones in the hand, appropriate immobilization and rehabilitation is necessary for the desired outcome.

10. These resorbable devices provide temporary fixation and are not intended to replace normal healthy bone or withstand stress of load bearing.

11. Patients that engage in stressful physical activities are to be warned that injury at or near the implant site can lead to failure of the device and/or the treatment.

12. Adequately instruct the patient. Postoperative care is important. The patient’s ability and willingness to follow instructions is one of the most important aspects of successful fracture management. Patients with senility, mental illness, alcoholism, or drug abuse may be at higher risk of device failure. These patients may ignore instructions and activity restrictions. The patient is to be instructed in the use of external supports, walking aids, and braces that are intended to immobilize the fracture site and limit weight bearing or load bearing. The patient is to be made fully aware and warned that the device does not replace normal healthy bone, and that the device can break, bend or be damaged as a result of stress, activity, load bearing, or weight bearing.

13. Noncompliance with postoperative instructions could lead to failure of the device, which could require additional surgery and device removal.

14. Inadequate fixation at the time of surgery can increase the risk of loosening and migration of the device or tissue supported by the device. Sufficient bone quantity and quality are important to adequate fixation and success of the procedure. Bone quality must be assessed at the time of surgery. Adequate fixation in diseased bone may be more difficult. Patients with poor quality bone, such as osteoporotic bone, are at greater risk of device loosening and procedure failure.

15. Cutting of Screws: The screw can be cut with an oscillating or reciprocating saw. No other cutting method may be used. After implantation, screws should only be cut at the distal protrusion.

16. These devices should not be used for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

PRECAUTIONS 1. Do not use Biomet Resorbable implants with resorbable implants

made by other manufacturers due to the probability of incompatible fits, size and rate of resorption.

2. Instruments are available to aid in the accurate implantation of Biomet Resorbable Fixations Devices. Intraoperative fracture of instruments has been reported. Surgical instruments are subject to wear with normal usage. Instruments, which have experienced extensive use or excessive force, are susceptible to fracture. Surgical instruments are only to be used for their intended purpose. All instruments are to be regularly inspected for wear and disfigurement.

3. The patient is to be made aware of the surgical risks and possible adverse effects prior to surgery, and warned that failure to follow postoperative care instructions can cause failure of the implant and the treatment.

POSSIBLE ADVERSE EFFECTS 1. Infection can lead to failure of the procedure. 2. Neurovascular injuries can occur due to surgical trauma. 3. Bending, fracture, loosening, rubbing and migration of the devices

can occur as a result of excessive activity, trauma or load bearing. 4. Implantation of foreign materials can result in an inflammatory

response or allergic reaction. 5. Nonunion, delayed union, or incomplete healing which may lead to

breakage of the implant or failure of the treatment. 6. Pain, discomfort, or abnormal sensation due to the presence of the

device. 7. Disfigurement may occur due to improper alignment of bone

fragments. 8. Necrosis of Bone. 9. Inadequate healing.

STERILITYResorbable implants are sterilized by exposure to Ethylene Oxide (ETO) Gas. Do not resterilize. Do not use past expiration date.

STORE AT OR BELOW ROOM TEMPERATURE. DO NOT EXPOSE PRODUCT TO TEMPERATURES GREATER THAN 120O F OR 49OC.

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

Comments regarding this device can be directed to Attn: Regulatory Dept., Biomet Inc., P.O. Box 587, Warsaw, IN 46580 USA, Fax: 574-372-1683.

The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package insert, please contact Arthrotek at the contact information provided herein.